I.S. EN ISO 6717:2021
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
Hardcopy , PDF
English
26-09-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Filling capacity/draw volume
6 Graduation lines
7 Design
8 Construction
9 Sterility and special microbiological states
10 Additives
11 Marking and labelling
Annex A (normative) Tests for filling capacity and/or graduation lines for non-evacuated specimen container
Annex B (normative) Draw volume test for evacuated containers
Annex C (normative) Test for leakage from the closure of a container
Annex D (normative) Test for the robustness of a container that is intended for centrifugation
Bibliography
This document specifies requirements and test methods for specialized single-use evacuated and nonevacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.
| Committee |
ISO/TC 76
|
| DocumentType |
Standard
|
| Pages |
30
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 6717:2021 | Identical |
| EN ISO 6717:2021 | Identical |
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